Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents

NCT01319812 | Completed Phase 2 Results

• 1 other identifier: BIOFLEX-I
• Study Type: interventional
• Target: 463
• Locations: 2 countries
• Sites: 35

Brief Summary

The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease

Keywords

Vascular intervention; Endovascular; Peripheral stent

Outcome Measures

Primary Outcomes (4)

• Effectiveness Endpoint for the Pulsar Stent: Primary Patency

  The primary effectiveness endpoint for the Pulsar stent group is the primary patency rate at 12 months post-index procedure. Primary patency is defined as freedom from more than 50% restenosis based on the duplex ultrasound peak systolic velocity ratio, comparing data within the treated segment to the proximal normal segment or based on a clinically-indicated TLR with angiographic evidence of \> 50% stenosis.

  12 months

• Safety Endpoint for the Pulsar Stent: Freedom From Procedure- or Stent-related Major Adverse Events

  The primary safety endpoint for the Pulsar stent is the freedom from procedure- or stent-related major adverse events at 30 days post-index procedure. The major adverse event rate includes mortality, target lesion revascularization and index limb amputation.

  30 days

• Safety and Effectiveness Endpoint for the Astron Stent - Percentage of Participants With Major Adverse Events (MAE)

  The primary endpoint for the Astron stent is a composite of the rate of procedure- or stent-related major adverse events at 12 months post-index procedure. The major adverse event rate includes 30-day mortality, along with 12-month rates of target lesion revascularization and index limb amputation. Success was measured against a performance goal of 15%, given a 7.5% expected 12-month MAE rate, with an assumed delta value of 7.5%.

  12 months

• Percentage of Participants With Primary Safety Endpoint (Post Market Analysis)

  Freedom from a composite of clinically-driven target lesion revascularization (TLR) and index limb amputation at 36 months.

  36 Months

Secondary Outcomes (37)

• Secondary Safety Assessment for the Pulsar Stent: Individual Rates of Mortality, TLR, and Index Limb Amputation

  30 days

• Long-Term Safety Assessment for the Pulsar Stent: Major Adverse Event Rate

  12 months

• Stent Integrity Assessment for the Pulsar Stent: Stent Fracture Rate

  12 months

• Secondary Safety Assessment for the Astron Stent - Distribution of MAE Rate

  12 months

• Secondary Effectiveness Assessment for the Astron Stent - Primary Patency Rate

  12 months

Study Arms (2)

Astron Stent Group

EXPERIMENTAL

Participants indicated for stenting in iliac atherosclerotic lesions. Intervention: Device: Astron Stents

Device: Astron Stents

Pulsar Stent Group

EXPERIMENTAL

Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions. Intervention: Device: Pulsar Stents

Device: Pulsar Stents

Interventions

Astron Stents DEVICE

Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery.

Also known as: Astron Stent

Astron Stent Group

Pulsar Stents DEVICE

Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries.

Also known as: Astron Pulsar Stent, Pulsar-18 Stent, Pulsar Stent

Pulsar Stent Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Willingness to comply with study follow-up requirements
• Candidate for PTA
• Life-style limiting claudication or rest pain with an ABI ≤ 0.9 (resting or exercise). Thigh brachial index (TBI) may be used / performed if ABI is inadequate.
• Written informed consent
• For a subject to receive an investigational stent, the following procedure-related criteria must be met:
• One de novo, restenotic or occluded lesion representing a femoro-popliteal or iliac indication OR Two de novo, restenotic or occluded lesions representing one femoro-popliteal indication and one iliac indication on contralateral limbs - (i.e. one lesion per limb)
• Lesions may be one solid lesion or a series of multiple, smaller lesions to be treated as one lesion
• Subjects with bilateral, SFA/PPA disease (i.e. one SFA/PPA lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral SFA/PPA intervention may be performed at the time of the index procedure (prior to treatment of study lesion); however, the use of an investigational treatment is prohibited. If the contralateral SFA/PPA intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the contralateral intervention is prohibited.
• Subjects with bilateral, iliac disease (i.e. one iliac lesion per limb) are eligible for enrollment into the study. The target lesion will be selected at the investigator's discretion based on study eligibility criteria. The contralateral iliac intervention may be performed at the time of the index procedure; however, the use of an investigational treatment is prohibited. If the contralateral iliac intervention is not performed at the time of the index procedure, the intervention must be performed at least 30 days after the index procedure. The use of an investigational treatment for the subsequent contralateral intervention is also prohibited.
• Femoro-popliteal lesions must be located at least 1 cm distal to the profunda femoris artery and at least 3 cm above the knee joint (radiographic joint space)
• Iliac lesions must be located only in either the common or external iliac artery
• Lesions must be treatable with a maximum of two stents
• Angiographic evidence of ≥ 70% stenosis or occlusion (operator visual assessment)
• Lesion length ≤ 190 mm (if de novo or restenotic) or ≤ 100 mm (if occluded)

You may not qualify if:

• Subjects pregnant or planning to become pregnant during the course of the study
• Life expectancy of less than one year
• Rutherford-Becker category 5 or 6. Subjects with ulcers caused by venous disease may be enrolled in the study.
• Previously stented lesion(s) in the target vessel
• Target lesion(s) received previous treatment within 30 days prior to enrollment
• Prior peripheral vascular bypass surgery involving the target limb(s)
• Thrombophlebitis or deep vein thrombosis within the past 30 days
• Known allergy to nitinol (nickel and/or titanium)
• Participation in any other clinical investigational device or drug study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.
• Previous stroke or transient ischemic attack within the last three months prior to enrollment
• Previous coronary or peripheral bypass surgery (non-target limb) within 30 days prior to enrollment
• Intolerance to contrast agents that cannot be medically managed and/or intolerance to anti-platelet, anti-coagulant or thrombolytic medications
• Refuses blood transfusions
• Any medical condition, that in the opinion of the investigator, poses an unacceptable risk for implant of a stent according to the study indications
• For a subject to receive an investigational stent the following procedure-related criteria must not be present:

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (35)

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Fremont, California, 94538, United States

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New Haven, Connecticut, 06510, United States

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Washington D.C., District of Columbia, 20010, United States

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Rockford, Illinois, 61107, United States

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Munster, Indiana, 46321, United States

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Houma, Louisiana, 70360, United States

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Lansing, Michigan, 48912, United States

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Saginaw, Michigan, 48601, United States

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Wyoming, Michigan, 49519, United States

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Ypsilanti, Michigan, 48197, United States

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Tupelo, Mississippi, 38801, United States

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Kansas City, Missouri, 64114, United States

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Ridgewood, New Jersey, 07450, United States

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New York, New York, 10065, United States

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The Bronx, New York, 10467, United States

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Gastonia, North Carolina, 28054, United States

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High Point, North Carolina, 27262, United States

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Cincinnati, Ohio, 45267, United States

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Toledo, Ohio, 43606, United States

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Toledo, Ohio, 43614, United States

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Camp Hill, Pennsylvania, 17011, United States

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Doylestown, Pennsylvania, 18901, United States

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Langhorne, Pennsylvania, 19047, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Providence, Rhode Island, 02906, United States

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Greenville, South Carolina, 29605, United States

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Rock Hill, South Carolina, 29732, United States

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Kingsport, Tennessee, 37660, United States

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Amarillo, Texas, 79106, United States

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Austin, Texas, 78745, United States

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McKinney, Texas, 75069, United States

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Tyler, Texas, 75701, United States

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Waco, Texas, 76712, United States

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Montreal, Canada

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Toronto, Canada

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Related Publications (1)

• Burket MW, Brodmann M, Metzger C, Tan K, Jaff MR. Twelve-Month Results of the Nitinol Astron Stent in Iliac Artery Lesions. J Vasc Interv Radiol. 2016 Nov;27(11):1650-1656.e1. doi: 10.1016/j.jvir.2016.06.008. Epub 2016 Aug 16.

  PMID: 27542591 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Amy Culley, Director of Vascular Intervention
• Organization: BIOTRONIK

amy.culley@biotronik.com

503-451-8034

Study Officials

• Mark Burket, MD

  University of Toledo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 22, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 7, 2017
• Last Updated: March 21, 2019
• Results First Posted: June 5, 2017

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (33); CA (2)